FDA Signs Off Chemomab's Lead Candidate Mid-Stage Study In Bile Duct Disease

The FDA has cleared Chemomab Therapeutics Ltd's CMMB Investigational New Drug (IND) application for CM-101 for the rare disease primary sclerosing cholangitis (PSC). CM-101, a first-in-class CCL24-neutralizing antibody, is Chemomab's lead clinical candidate.

• The Phase 2 SPRING trial assessing CM-101 as a potential treatment for PSC is already underway in Europe and Israel and is now being expanded to include U.S. sites.
• The SPRING trial is designed to evaluate the safety and efficacy of CM-101 over 15 weeks of treatment in patients with PSC.
• The initial clinical readout is expected in 2022.
• CM-101 appeared safe and well-tolerated in Phase 1a and 1b clinical studies in healthy volunteers and non-alcoholic fatty liver disease (NAFLD) patients. 
• Primary sclerosing cholangitis is a rare and severe disease of the bile ducts in the liver. 
• See here Benzinga's Full FDA Calendar.
• Price Action: CMMB shares are up 14.90% at $9.69 during the premarket session on the last check Thursday.